Antimicrobial light-emitting percutaneous site dressing

ABSTRACT

An antimicrobial light dressing device, system and method for a percutaneous treatment that bathes a treatment region around the percutaneous insertion with an antibacterial illumination source for preventing pathogens around the insertion from entering via the dermal puncture created by the insertion. The antimicrobial light dressing device combines a circumferential body centered around the insertion, and an arrangement of LEDs around the body that focus the light around the insertion and onto a therapeutic region of the insertion. An opening in the circumferential body has an articulated protrusion for offsetting a medicinal vessel such as an IV tube off the skin surface to avoid blocking light to an area under the vessel.

RELATED APPLICATIONS

This patent application claims the benefit under 35 U.S.C. § 119(e) ofU.S. Provisional Patent App. No. 63/146,697, filed Feb. 7, 2021,entitled “ANTIMICROBIAL LIGHT DRESSING DEVICE,” incorporated herein byreference in entirety.

BACKGROUND

Intravenous (IV) access is a common medical practice for direct fluidcommunication with blood vessels. A sharp, rigid member such as a needleis inserted into a dermal (skin) surface for piercing the dermal surfaceand extending into a blood vessel, or alternatively into a tissueregion. While often employed for medicinal delivery, an sharp, insertedmember may also be employed for fluid removal, such as testing samplesand relief of excess fluid buildup. Whatever the therapeutic motivation,such a breach in the epidermal surface presents a pathway for infectionfrom pathogens traversing the breached skin barrier

SUMMARY

Configurations herein are based, in part, on the observation thatpercutaneous delivery of medication is an effective medium for medicinaltreatment directly to blood or tissue, which allows the medication to bequickly delivered to a specific region. In the case of generalbloodstream delivery, it avoids degradation that can occur by oraladministration which must pass via the gastrointestinal barrier.Unfortunately, conventional approaches to percutaneous delivery,typically via a needle or similar insertion member, suffer from theshortcoming that they pose an infection risk from a breach of thenatural dermal (skin) barrier which guards against infiltration ofpathogens. Typically, an antimicrobial substance is applied around theinsertion point of the needle, however such chemical based approachesgenerally have diminishing effects over time, and need repeatedapplications for continued effectiveness.

Accordingly, configurations herein substantially overcome theshortcomings of chemical and topical approaches by providing anantimicrobial light dressing device, system and method for apercutaneous treatment that bathes a treatment region around thepercutaneous insertion with an antibacterial illumination source forpreventing pathogens around the insertion from entering via the dermalpuncture created by the insertion. The antimicrobial light dressingdevice combines a circumferential body centered around the insertion,and an arrangement of LEDs around the body that focus the light aroundthe insertion and onto a therapeutic region of the insertion. An openingin the circumferential body has an articulated protrusion for offsettinga medicinal vessel such as an IV tube off the skin surface to avoidblocking light to an area under the vessel. The result is a 360 degreecoverage of antimicrobial light around the percutaneous insertion as themedicinal vessel contacts the skin surface only at the insertion pointin the center of the treatment region.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of theinvention will be apparent from the following description of particularembodiments of the invention, as illustrated in the accompanyingdrawings in which like reference characters refer to the same partsthroughout the different views. The drawings are not necessarily toscale, emphasis instead being placed upon illustrating the principles ofthe invention.

FIG. 1 is a context view of a medical treatment environment suitable foruse with configurations herein;

FIG. 2 is a perspective view of the medical device for antimicrobiallight treatment of a percutaneous insertion site;

FIGS. 3A-3C show engagement of the device of FIG. 2 with a treatmentregion defined by the percutaneous insertion site;

FIGS. 4A-4B show perspective views of a central void in the device ofFIGS. 1-3 c;

FIG. 5 shows a plan view of the device of FIGS. 1-4B;

FIG. 6 shows a side, cutaway view of the central void and illuminationcavity formed by the device of FIGS. 1-5;

FIG. 7 shows a perspective view of the illumination cavity of FIG. 6;

FIG. 8 shows a bottom view of the device of FIGS. 1-7;

FIG. 9 shows an underside perspective view of the device andillumination/light cavity of FIGS. 6-8; and

FIG. 10 shows a method of applying the antimicrobial light treatment ofFIGS. 1-9.

DETAILED DESCRIPTION

A device for the dressing of wounds and insertion sites of percutaneousand drug delivery devices provides circumferential protection of a woundor insertion site of a percutaneous or drug delivery device. Inparticular, the device is an integrated dressing for vascular andnon-vascular percutaneous medical devices (e.g., IV catheters, centralvenous lines, arterial catheters, dialysis catheters, peripherallyinserted coronary catheters, mid-line catheter, drains, chest tubes,externally placed orthopedic pins, ventricular assist device drivelines,and epidural catheters) comprising an adhesive dressing and anantimicrobial light source, such as visible light, far UVC light, andany suitable electromagnetic emission of a therapeutically beneficialwavelength. The dressing device reduces infection risk from vascular andnon-vascular percutaneous medical devices by providing sufficienttissue-safe antimicrobial light at a wound or insertion site.

FIG. 1 is a context view of a medical treatment environment suitable foruse with configurations herein. Referring to FIG. 1, an antimicrobialepidermal device 100 includes a circumferential light-emitting body 110configured for adhesion around a percutaneous insertion site 52 fordirecting therapeutic light at the percutaneous insertion site whilepermitting unobstructed passage of a medication vessel 140 to thepercutaneous insertion site 52. The medication vessel emanates from afluidic source 142 of medication or other liquid, such as an IV(Intravenous) bag. The percutaneous insertion site 52 defines asurrounding treatment region 50, typically on an arm of a patient 145because of ease of IV access, however any suitable epidermal region maybe selected for the percutaneous insertion site.

In the antimicrobial epidermal device 100, the circumferential body 110is adapted for epidermal placement on the treatment region 50 of alarger epidermal surface 10. Placement is based on a central void 120 inthe circumferential body for epidermal access and alignment generallyover the insertion site 52. The circumferential body 110 includes anillumination source disposed for emitting a therapeutic light on thetreatment region 50 defined by the central void 120. An adhesive member116, such as a patch or bandage, adheres the circumferential body 110,vessel 140 and a percutaneous penetration member such as a needle to theepidermal area around the treatment region 50.

FIG. 2 is a perspective view of the medical device of FIG. 1 forantimicrobial light treatment around a percutaneous insertion site 52.FIG. 2 shows the central void 120 accessible by a vessel gap 122 in thecircumferential body 110 for passage of the medication vessel 140 to apenetration or insertion member defining the insertion site 52. Thetreatment region 50 is defined by a radius around the insertion siteroughly centered within the circumferential body. In the example of FIG.2, the central void 120 remains covered by an insert 121 except at thevessel gap 122 for permitting vessel access into an illumination cavity118.

FIGS. 3A-3C show engagement of the device of FIG. 2 with a treatmentregion defined by the percutaneous insertion site. In a particularconfiguration, the device may be combined with an adhesive member 116such as a sheet, patch or bandage for providing a system of secureattachment of the illumination source to the percutaneous insertionsite. Referring to FIGS. 1-3C, the circumferential body 110 is disposedon an epidermal surface 10, in conjunction with an adhesive member 116.The adhesive member 116 has an adhesive attraction to the epidermalsurface 10 and extends over the treatment region 50 and is disposed forsecuring the circumferential body 110 and a treatment vessel 140directed to the central void 120. The adhesive member my include asecurement or fixation dressing having adhesive and therapeutic orantimicrobial properties. The securement or fixation dressing isdisposed between the circumferential body 110 and the epidermal surface10, The circumferential body is therefore disposed in place by theunderlying securement or fixation dressing/patch, and substantiallycentered around the insertion site.

The configuration of FIG. 3 shows a two-part configuration of thedevice. The circumferential body 110 further includes a distal layer110-2 including a power connection 111 for powering an illuminationsource such as one or more LED elements and a proximate layer 110-1having a translucent surface, in which the LED elements are disposedwithin the distal layer 110-2 for directing the therapeutic light ontothe treatment region 50.

The proximate layer 110-1 engages with the adhesive member 116, whichmay be integrated as an adhesive whole or applied in separate phases. Inthe configuration of FIGS. 3A-3C, the adhesive member 116 may residebetween the proximate layer 110-1 and distal layer 110-2. The adhesivemember 116 secures the insertion member at the insertion site 52 alonewith the medication vessel 140, shown in FIG. 3A. The treatment region50 is defined by a radius around the dermal insertion site 52, where theinsertion site 52 provides the dermal access for medical interventionthrough the skin by a sharp, piercing structure.

In FIG. 3B, the distal layer 110-2 approaches the secured, proximatelayer 110-1. The distal layer 110-2 may already be emitting light 54onto the treatment region 50. In FIG. 3C, the distal layer 110-2 engagesthe proximate portion 110-2 to form the full circumferential member 110,and encapsulates an illumination cavity, discussed further below.

FIGS. 4A-4B show perspective views of a central void 120 in the deviceof FIGS. 1-3 c. Referring to FIGS. 1-4B, upon adherence and properadministration, the circumferential body 110 adheres to the epidermalsurface 10 with the central void 120 roughly centered on the insertionsite 52. An illumination source 130 includes at least one LED elementdefining the illumination source, in which the LED element emits awavelength based on an antimicrobial effect. The central void 120 has asize based on a treatment vessel 140 size and clearance over theinsertion site 152. The treatment vessel 140 has an attachment to theinsertion member such as a needle for a percutaneous insertion under thecentral void. The vessel extends through the vessel gap 122 and throughthe central void 120 or at least through the gao 122 and into theillumination cavity 118.

A power connection 113 receives the power supply 111 on thecircumferential body 110. The power supply couples to the illuminationsource 130 and is adapted for receiving an electrical source forpowering the illumination source, such as an external USB, batteries, ACor similar AC or DC source based on the electrical requirements of theillumination source 30. A discontinuity in the circumferential bodydefines the vessel gap 122 for accommodating the treatment vessel 140.The treatment vessel 140 couples to the percutaneous insertion member inthe treatment region 50 under the central void 120. Routing of thetreatment vessel 140 is provided by a protrusion 124 extending outwardfrom the circumferential body. The protrusion 124 has an elevatedsurface 126 disposed away from the epidermal surface 10, such that theelevated surface 126 is adjacent the vessel gap 122 for directing thetreatment vessel at an offset distance from the dermal surface 10.Elevation of the treatment vessel 140 above the skin avoids a shadowfrom the light and instead allows a shadowed region 125 to be reached bylight from the illumination source 130 rather than being shaded orobscured by the vessel 140 from reaching the skin at the shadowedregion.

FIG. 5 shows a plan view of the device of FIGS. 1-4B. Referring to FIGS.1-5, the vessel gap 122 is an opening or passage in the circumferentialbody 110. A lateral extension 128 extends radially from thecircumferential body 110 adjacent the vessel gap 122, and turns towardthe gap 122 to provide the elevated surface 126 residing on theprotrusion 124. The elevated surface 126 is disposed on a path towardsthe central void 120 for receiving a treatment vessel 140 disposed onthe path for fluidic delivery to an insertion site 52 in the treatmentregion 50.

FIG. 6 shows a side, cutaway view of the central void and light cavityformed by the device of FIGS. 1-5. Referring to FIGS. 1-6, a pluralityof LED elements 132-1 . . . 132-2 (132 generally) surround theillumination cavity 118, although as few as 1 could be provided. In theexample configuration, the plurality of LED elements 132 are disposedgenerally in a circle around the circumferential body 110, and fill theillumination cavity 118 with light focused on the treatment region 50.The inner surface of the circumferential body 110 and optional insert121 are a light color and may be translucent to reflect and refract(distribute and target) as much if the light as possible around theillumination cavity 118 to fall on the treatment region 50. Theantimicrobial light is therefore specifically targeted to fall on thetreatment region defined by the percutaneous insertion and surroundingepidermal region, specifically within the illumination cavity 118 of thecircumferential body 110.

FIG. 7 shows a perspective view of the light cavity of FIG. 6 as acutaway from the circumferential body 110. Referring to FIGS. 1-7, thecircumferential body 110 is disposed on a treatment region 50 andcentered on or around an insertion site 52 of a percutaneous insertionmember. One or more LED elements 132-N disposed on an inner surface 123of the circumferential body bathe the illumination cavity 118 in lightfor directing the light directly on the treatment region 50 and alsoreflected and/or refracted around the inner surface 123 as shown byarrows 134. A light colored, translucent and/or reflective property ofthe inner surface 123 generally focuses direct and indirect light ontothe treatment region 50 for eliminating harmful pathogens that may liveon the skin surface around the insertion site 52.

FIG. 8 shows a bottom view of the device of FIGS. 1-7. Referring toFIGS. 7-8, FIG. 8 shows four LEDs 132-1 . . . 132-4 emanating from theinner surface 123, however any suitable number of LEDs may be providedbased on the intensity and wavelength of the therapeutic light soughtfor irradiation. Any suitable propagated wavelength of theelectromagnetic spectrum may be provided if an illumination element canbe so equipped. The underside 108 rests on the dermal surface 10 at thetreatment region, adhered by the adhesive member 116 as discussed above.The protrusion 124 has a bottom flush with the underside 128, and opensto define the illumination cavity 118. The lateral extension 128 isflush with the underside 128 for resting on the skin surface, andextends in an articulated manner for protrusion 124 to form the elevatedsurface 126 at the vessel gap 122.

FIG. 9 shows an underside perspective view of the device andillumination cavity 118 of FIGS. 6-8. The illumination cavity 118 isbased on a generally concave region under the central gap 120 andextending to an inner perimeter 119 of the circumferential body 110,with the vessel gap 122 allowing passage of the treatment vessel 140.

FIG. 10 shows a method of applying the antimicrobial light treatment ofFIGS. 1-9. Referring to FIGS. 1-10, a method for antimicrobial lighttreatment of a percutaneous insertion site as shown in FIG. 10 includesapplying an adhesive member 116 to a treatment region 50 for securing apercutaneous insertion member in an insertion site. The percutaneousinsertion member 150, such as a needle, is in fluidic communication witha medication vessel 140 for delivering medication, typically an IV line,infusion line or similar delivery system. The adhesive member 116 mayadhere on the epidermal surface, shown as dotted line 116′, or may beapplied over the circumferential member 110, shown as dotted line 116″.In the alternate configuration of FIGS. 3A-3B, the adhesive member 116″may reside between the proximate layer 110-1 and distal layer 110-2.

In either configuration, the circumferential body 110 is disposed ontothe treatment region 52. The circumferential body 110 extends generallycircular around a central void 120, and placement centers the centralvoid around the insertion site so that the central void allows clearancefor the medication vessel 140 and any uninserted portion of the rigidinsertion member. The circumferential body 110 may be any suitable shapeand size based on the treatment region 50 and the intensity of theillumination source 130 thereby irradiating the treatment region.

The circumferential body 110 includes a discontinuous portion definingthe vessel gap 122, which may be continuous with the central void 120.In conjunction with placement of the circumferential body 110, themedication vessel is routed over the elevated surface 126 on theprotrusion 124 extending from the circumferential body for permittingthe vessel to extending through the vessel gap 122 above and out ofcontact with the skin surface. The treatment region 50 is illuminatedfrom one or more LEDs (Light Emitting Diodes) 132 disposed on an innersurface of the circumferential body 110 for irradiating an illuminationcavity 118 defined by the inner surface and the central void. The LEDs132 or other illumination source irradiate the treatment region formaintaining an antimicrobial and sterile environment around theinsertion site 50. This prevents pathogens from entering the patientalong the insertion member 150.

In a particular configuration shown in FIGS. 3A-3C above, thecircumferential body has multiple, engageable parts. A first, proximatelayer 110-1 accompanies the insertion member 150. Disposing thecircumferential body 110 further comprises disposing the proximate layer110-1 by applying a proximate layer centered on the treatment regionusing the adhesive member 116, and engaging the distal layer 110-2 ontothe proximate layer 116-1 by circumferentially aligning the distal layerwith the proximate layer, the LEDs directed towards the illuminationcavity. Any suitable adhesive, friction, interference and/or deformable(i.e. snap-fit plastic tab) mechanism may be employed for engaging theproximate 110-1 and distal 110-2 layers.

While the system and methods defined herein have been particularly shownand described with references to embodiments thereof, it will beunderstood by those skilled in the art that various changes in form anddetails may be made therein without departing from the scope of theinvention encompassed by the appended claims.

What is claimed is:
 1. A device, comprising: a light-emitting bodyconfigured for directing antimicrobial light at a percutaneous insertionsite.
 2. The device of claim 1 wherein the light emitting body isconfigured for directing targeted antimicrobial light circumferentiallyat the percutaneous insertion site.
 3. The device of claim 2 furthercomprising a central void in the light emitting body for unobstructedpassage of a percutaneous device.
 4. The device of claim 1 wherein theantimicrobial light is ultraviolet light for reducing an infection riskfrom a percutaneous medical device inserted at the insertion site. 5.The device of claim 1 wherein the antimicrobial light is visible lightfor reducing an infection risk from a percutaneous medical deviceinserted at the insertion site.
 6. The device of claim 1 wherein thelight emitting body is configured for directing targeted antimicrobiallight at the percutaneous insertion site.
 7. The device of claim 1wherein the light emitting body is configured for directing targetedultraviolet and/or visible light at the percutaneous insertion site. 8.The device of claim 1 further comprising at least one of a dressing,antimicrobial agent, securement dressing, fixation dressing ortransparent dressing disposed between the light emitting body and thepercutaneous insertion site.
 9. An antimicrobial device, comprising: abody adapted for placement on the skin around a percutaneous device; andan illumination source disposed for emitting antimicrobial light at apercutaneous insertion site.
 10. The device of claim 9 furthercomprising at least one LED element defining the illumination source,the LED element emitting an antimicrobial light.
 11. The device of claim9 further comprising a plurality of LED elements, the plurality of LEDelements disposed around the body, each of the LED elements focused onthe insertion site.
 12. The device of claim 9 wherein the body furthercomprises a distal layer including a power connection for powering theat least one LED element and a proximate layer, the proximate layerinterfacing with an underlying dressing, skin, or antimicrobial agent.13. The device of claim 9 wherein the percutaneous insertion site isaround the indwelling percutaneous device or instrument.
 14. The deviceof claim 9 wherein the central void has a size based on a percutaneousdevice or instrument.
 15. The device of claim 9 further comprising adiscontinuity in the body, the discontinuity defining a gap foraccommodating a percutaneous device or instrument.
 16. The device ofclaim 15 further comprising a protrusion extending outward from thebody, the protrusion having an elevated surface disposed away from theskin surface, the elevated surface adjacent the percutaneous device orgap for directing the percutaneous device or instrument at an offsetdistance from the dermal surface.
 17. The device of claim 9 furthercomprising: a gap in the body; a lateral extension extending radiallyfrom the body adjacent the gap; and an elevated surface on the lateralextension, the elevated surface disposed on a path towards the centralvoid for receiving a percutaneous device or instrument, the percutaneousdevice or instrument disposed on the path into the body through thepercutaneous insertion site.
 18. The device of claim 9 furthercomprising a power connection on the body, the power connection coupledto the illumination source and adapted for receiving an electricalsource for powering the illumination source.
 19. The device of claim 9wherein the body is disposed on a skin surface, further comprising anadhesive member, the adhesive member having an adhesive attraction tothe skin surface and extending over the treatment region and disposedfor securing the body and a percutaneous device or instrument directedto a central void.
 20. A method for reducing infection risk frompercutaneous devices or instruments, comprising targeting antimicrobiallight at the insertion site.
 21. The method of claim 20, whereintargeting the antimicrobial light further comprises: disposing anantimicrobial light emitting body around the percutaneous insertionsite; and illuminating the treatment region from one or more LEDsdisposed on an inner surface of the body for circumferentiallyirradiating percutaneous insertion site.
 22. The method of claim 21wherein disposing the body further comprises: disposing a proximatelayer centered on the percutaneous insertion site comprising anunderlying dressing, antimicrobial, or skin directly; activating the oneor more LEDs, the LEDs disposed on a distal layer; and aligning thedistal layer on the proximate layer, the LEDs directed towards theinsertion site.
 23. The method of claim 20 wherein the antimicrobiallight comprises at least one of ultraviolet or visible spectrum light.24. A system comprising: an antimicrobial light-emitting device; and anattachment disposed between the antimicrobial light-emitting device,wherein the attachment affixes the targeted antimicrobial light towardsa percutaneous device insertion site.
 25. The system of claim 24 whereinthe attachment is a dressing.
 26. The system of claim 25 wherein theattachment further comprises a securement or fixation dressing.
 27. Thesystem of claim 25 wherein the dressing is transparent.
 28. The systemof claim 25 wherein the dressing is antimicrobial.
 29. The system ofclaim 24 wherein the dressing comprises an elevated surface adjacent thepercutaneous device or instrument for directing the percutaneous deviceor instrument at an offset distance from the dermal surface.